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Alpha-Stim 18-50-155614-1

by Parker Laboratories, Inc.

Alpha-Stim 18-50-155614-1 (SL50) is a Class II device made by Parker Laboratories, Inc., cleared under FDA 510(k) K780973 on 27 Jul 1978, registered in EUDAMED and listed in FDA GUDID since 12 Sep 2023 (UDI-DI 10855683006958), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K780973

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10855683006958 UDI-DI Date12 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK780973 Date27 Jul 1978DecidedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K780973 decided 27 Jul 1978 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 10855683006958 listed 12 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K780973
  2. Listed FDA GUDID 10855683006958

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Alpha-Stim
Generic name
Electrode conductive medium
Model / Ref / Catalog
18-50-155614-1, SL50
Primary DI / UDI-DI
10855683006958
510(k) Number
FDA product code
GYB
GMDN term
Electrode conductive medium
Device class
Class II
Regulation number
882.1275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrode conductive medium

Cleared under the same submission (K780973)

and 2 more cleared under K780973

Similar devices

Other devices filed under FDA product code GYB (Media, Electroconductive).

Other devices from Parker Laboratories, Inc.

See all devices from Parker Laboratories, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)